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U.S. Department of Health and Human Services

Class 2 Device Recall Colorado 2 Anterior Plate

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  Class 2 Device Recall Colorado 2 Anterior Plate see related information
Date Initiated by Firm February 02, 2007
Date Posted March 27, 2007
Recall Status1 Terminated 3 on August 11, 2007
Recall Number Z-0654-2007
Recall Event ID 37376
Product Classification spinal implant - Product Code KWQ
Product Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
Code Information Lot Nos.: W04E0149, W04C1938, 553880, 672660, 353150, 355610, 201190, 198840, 947250, 914870, 82549, 81749, 81320, 76967, 65867, 42841, 42842.
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132-1719
For Additional Information Contact Jill Serbousek
901-933-2912
Manufacturer Reason
for Recall		 Bone screws may pull though the plate.
FDA Determined
Cause 2		 Other
Action Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country.
Quantity in Commerce 293 units
Distribution France, Germany, Italy, UK, and Tunisia. No US distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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